Whitepapers

Example of how we offer creative and interesting solutions to our customers to improve efficiency in production.

We want to inform our customers that we have an excellent tech center available to assist them to develop together tailor-made solutions and personalized technologies, solve problems and complete hands-on training on our machines.

Highlighting the importance for our clients to prepurchase multi-year maintenance contracts, in order to avoid their machines breaking or stopping to work suddenly and unexpectedly, to minimize the risk of interrupted production and emergency maintenance costs.

Lipid nanoparticle (LNP) formulation development begins on a small scale, often with homemade or benchtop setups, using syringe pumps and easily accessible micro-mixing systems. Once a promising formulation has been identified, the next step is to transition to standardized large-scale impingement mixing systems, such as the high flow T-mixing pumps that were used to produce the COVID-19 vaccines (Sealy 2021). Formulators need to consider a number of factors when scaling up novel LNP systems. These include flow rates that affect LNP particles, solvent removal, risk factors when changing equipment, and the impact of tangential flow filtration sensitivity. In this technical note, we discuss these factors and what needs to be considered when developing a cost- and time efficient large-scale process.

A must-read for anyone in the industry looking to enhance their micronization processes. Discover how adding low percentages of SYLOID® mesoporous silica can significantly improve the run time and yield of jet milling processes for hard-to-process Active Pharmaceutical Ingredients (APIs). Imagine achieving a more consistent feed rate and a homogenous final product simply by pre-blending SYLOID® mesoporous silica with your APIs. Grace & Microsize conducted experiments that reveal substantial improvements in both run time and yield, making this paper an essential guide for professionals aiming to optimize their manufacturing processes and boost efficiency and feed rate consistency.

An article describing the technological advancement from one process controller to the new one.

Stevanato Group’s integrated offering addressing mAbs challenges includes Aidaptus®, a 2-step single-use auto-injector accommodating 1mL and 2.25mL PFSs in the same base device, supporting a range of drug viscosities for reliable delivery.

Don't miss this webinar delving into: - How to streamline the selection of the primary container and delivery device - How to overcome silicone challenges in PFSs - How to enhance the delivery of highly viscous drug formulation

The release of subvisible silicone particles and the risks associated with silicone oil droplets are major factors that can compromise the safety and efficacy of sensitive drugs. Download this white paper and discover how Stevanato Group's innovative syringe platform answers this challenge.

For new drug products, it is essential that pharmaceutical companies utilize the experience of container suppliers as early as possible. Read this white paper and discover how Stevanato Group can support you from start to finish.

Commercializing a drug-device combination product is a complex challenge to handle alone. Learn how Stevanato Group’s Technology Excellence Centers can provide guidance and execution through the various steps of a Validation Master Plan.

3D screen printing provides innovative drug development capabilities that are difficult or impossible to achieve with traditional methods, including complex multi-layered formulations, precision control over drug release profiles, and near-endless possibilities in the geometric shaping of dosage forms. In this article, learn how 3D screen printing offers unmatched flexibility to tailor formulations for specific therapeutic needs and redefines what’s possible in drug development and manufacturing.

Collaborating with a CDMO that has the necessary expertise, equipment, and systems in place is crucial to optimizing the scale-up process and accelerating timelines.

This article explores the challenges found in manufacturing of a pressure vessel as main component for freeze drying technology

ROSS Ribbon Blenders meet the toughest standards for quality and long-term performance. Known worldwide for heavy-duty robust construction, high quality materials and fine craftsmanship, these blenders are available in a variety of customizable configurations ranging from laboratory sizes to 1000 cubic feet. We pay close attention to every detail in design and fabrication, a commitment that translates to higher production value for the end user.

This white paper presents an overview of mixing technologies implemented across many of today’s highly competitive pharmaceutical and medical industries, as well as new equipment designs that are increasingly being recognized as potential solutions to prevailing mixing challenges. Mixing applications falling within the broad spectrum of mass produced pharmaceutical goods and medical devices are too many and complex to discuss in detail hence this paper will touch on a few general classifications as well as a few examples within that mixing category. Phase and viscosity are used as bases for classification.

An inline rotor/stator mixer equipped for powder induction offers flexibility, capability and portability to serve multiple mix vessels of virtually any size. Its straightforward operation and convenience further maximize equipment utility while simplifying material handling.

Consider upgrading your emulsification process to an ultra-high shear mixer to obtain finer droplet sizes and handle higher viscosity emulsions.

Tumble blenders deliver highly accurate and repeatable mixing of powders, granules and even low-viscosity slurries. In addition, this style blender enables complete discharge and easy cleaning. This bulletin presents some design considerations for maximizing mixing efficiency in a tumble blender and selecting the most suitable features for a particular application.

The dream state If we lived in an ideal world, it would be possible to unambiguously identify metabolites using a single analytical experiment. This analytical technique would need to be efficient and easily generate the information needed from a routine assay that is also robust, enabling confident decision-making during drug discovery. At SCIEX, we believe that metabolite identification using the ZenoTOF 7600 system gets close to this dream state.

Read about a material-sparing strategy for developing spray-dried intermediates (SDIs) and their tablet formulations, enhancing bioavailability for poorly soluble active pharmaceutical ingredients (APIs), using erlotinib as a case study. By integrating formulation mapping, polymer screening, and compact screening, the approach enables rapid risk identification and informed decision-making for first-round tablet formulations.

As a leader responsible for metabolite identification in your organization, what keeps you awake at night? SCIEX can give you peace of mind by helping you . . .

Here we discuss a software-assisted drug metabolite identification and characterization workflow. The approach allows scientists to have increased confidence in the process.

Many consumers trust that a Certificate of Analysis (COA) guarantees product safety, but without strict regulatory oversight, that’s not always the case. This white paper provides insights into what consumers and businesses should look for in a truly safe, high-quality, and consistent product.

The regulatory landscape for bioequivalence continues to evolve, leveraging a broader suite of characterization techniques. These not only provide deeper product understanding, but also utility for generic product development as the potential for replacement of costly clinical studies becomes more of a reality.

The identification, characterization, and quantitation of host cell protein (HCP) impurities are a critical challenge in the biopharmaceutical industry. Advanced LC-MS techniques can be integrated into manufacturing workflows to mitigate risks and ensure higher product quality and improved patient safety.